Eli Lilly Canada Inc. (Lilly Canada) is pleased to announce that Emgality® (galcanezumab) is now indicated for the reduction in the frequency of attacks throughout a cluster period in adults with episodic cluster headache with prior cluster headache periods lasting at least 6 weeks and who have had an inadequate response to, or tolerated poorly, or had contraindications to conventional preventive therapies established by Canadian practice guidelines
| TORONTO, Feb. 25, 2021 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada) is pleased to announce that Emgality® (galcanezumab) is now indicated for the reduction in the frequency of attacks throughout a cluster period in adults with episodic cluster headache with prior cluster headache periods lasting at least 6 weeks and who have had an inadequate response to, or tolerated poorly, or had contraindications to conventional preventive therapies established by Canadian practice guidelines. i This is the second indication for Emgality, making it the first and only calcitonin gene-related peptide (CGRP) binding monoclonal antibody approved in Canada to reduce the frequency of episodic cluster headache attacks that is also approved for the prevention of migraine in adults who have at least 4 migraine days per month.ii “This is good news for patients living with episodic cluster headache who have had an inadequate response to conventional preventive therapies. Cluster headache attacks are the worst pain known to humanity. Enduring many of these attacks every day, often waking you from sleep, is extremely disruptive. A new treatment that could rapidly decrease the frequency of attacks would be life-changing,” says Dr. Elizabeth Leroux, Headache Neurologist in Montreal and President of the Canadian Headache Society. “The approval provides physicians with an additional treatment option to help these patients who suffer from extreme pain.” Episodic cluster headache is a devastating primary headache disorder characterized by the abrupt onset of attacks of severe- to very severe pain on one side of the head, occurring in cluster periods lasting typically two weeks to three months.iii Most patients (90%) with cluster headache suffer from the episodic form, meaning they have remissions (with no attacks) of more than 3 months and the cluster periods do not last more than 1 year.iv Pain is felt around or above the eye and/or temple and can be accompanied by symptoms on the same side of the body: eye redness, tearing, nasal congestion, runny nose, forehead and facial sweating, constriction of the pupil, drooping eyelid and/or swollen eyelid, and/or restlessness or agitation.v These attacks last 15 to 180 minutes when untreated and can occur from once every other day to eight times per day.vi Cluster headaches can be so painful that sufferers are unable to follow their normal routine and activities.vii While episodic cluster headache is not as common as migraine, it does impair life for thousands of Canadians.viii About 1 in 1,000 adults have episodic cluster headache, with men affected 3:1 compared to women.ix About Emgalityx Emgality is administered subcutaneously through a single-use prefilled syringe or a prefilled pen and is intended for patient self-administration.
The recommended dose of Emgality for episodic cluster headache is 300 mg once a month (administered as three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. Treatment benefit should be assessed within 3 weeks of the initiation of treatment. In patients with no improvement within this time, any further decisions for continuation of the treatment should be carefully considered based on individual patient basis and clinical judgement.xii The science of Emgality for episodic cluster headachexiii CGAL was a randomized, multicenter double-blind placebo-controlled study in adults who met diagnostic criteria for episodic cluster headache and had a prior history of a cluster period lasting 6 weeks or longer. In CGAL, patients were randomized at the initiation of phase 3 (1:1) to receive subcutaneous injections of either Emgality 300 mg once a month or placebo once a month, over an 8-week treatment period. During the prospective 7-day baseline assessment, patients were required to have a maximum of 8 attacks per day, a minimum of one attack every other day, and at least 4 attacks. The primary efficacy endpoint was the mean change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3, with baseline defined as 7 consecutive days from the daily ePRO diary during the prospective baseline assessment. The key secondary endpoint was the proportion of patients achieving response (defined as a reduction from baseline of 50% or greater in the weekly cluster headache attack frequency) at Week 3. The primary endpoint (Weeks 1-3) and gated secondary endpoint (at Week 3) of Study CGAL measured the effect of only one dose of Emgality.
In the CGAL study, injection site pain was the most frequently reported adverse event (8%). The majority of injection site reactions, including pain, were reported within 1 day and most resolved within a few days. Most events were mild to moderate and did not lead to discontinuation of Emgality. For full prescribing information, including Patient Information, please refer to the Canadian Product Monograph for Emgality, available at www.lilly.ca. About Lilly Canada Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world’s first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca. For our perspective on issues in healthcare and innovation, follow us on Twitter @LillyPadCA Lilly Cautionary Statement Regarding Forward-Looking Statements References
SOURCE Eli Lilly Canada | ||||||||||||||||||||||||||||||||